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Wednesday, May 14, 2025 | 11am ET / 8am PT Biotech success isn’t just about great science—it’s about building a compelling commercial narrative from day one. Join us to explore how early commercialization planning, powered by real-world insights, can maximize an asset’s potential. Our discussion will uncover strategies to integrate commercial thinking into R&D. Register now.
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Today’s Big NewsMay 9, 2025 |
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These studies reveal a drug’s active free fraction, which impacts safety and efficacy. QPS experts explain the methods to determine plasma protein binding. Download the QPS white paper: Plasma Protein Binding
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| By Kevin Dunleavy Verastem Oncology has gained its first FDA approval, winning an accelerated nod for the combination treatment of avutometinib and defactinib for a rare form of ovarian cancer. With the commercial name of Avmapki Fakzynja Co-Pack, the combo becomes the first treatment specifically for patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC). It affects between 6,000 and 8,000 women in the U.S. and 80,000 globally. |
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By Nick Paul Taylor Sanofi has scrapped its collaboration with IGM Biosciences, eliminating the biotech’s last program in the process. IGM responded by laying off 80% of its staff and closing most of its lab and office facilities. |
By Conor Hale The company said its Zoom DuoPort approach enables uninterrupted aspiration during thrombectomy by connecting two catheters to a single vacuum source. |
By Fraiser Kansteiner Roche is investing roughly $282 million to erect a new biomanufacturing hub in Shanghai. The plant, which will mark Roche’s second for branded medicines in the country, will mainly be used for domestic production of the eye med Vabysmo., |
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Thursday, May 15, 2025 | 12pm ET / 9am PT Join this webinar for a deep dive into today’s biotech investment climate and practical strategies to navigate commercialization when pharma partnerships are delayed or uncertain.
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By Nick Paul Taylor The National Institutes of Health terminated $1.8 billion in grants in fewer than 40 days as part of a whirlwind of cuts early in the Trump administration, according to research published in JAMA. |
By Zoey Becker The addition of Imfinzi to standard-of-care Bacillus Calmette-Guérin (BCG) induction and maintenance therapy helped patients live longer without their disease coming back, AstraZeneca said on Friday. |
By Gabrielle Masson Vir Biotechnology’s sidelined hepatitis B candidate, designed to serve as a “functional cure,” has failed to achieve the efficacy results hoped for in a midstage study. |
By Angus Liu Enhertu delivered a trial win in early-stage breast cancer. Takeda spotlighted three late-stage readouts as a potential "inflection point" for the company. President Donald Trump is directing the FDA to go hard on foreign manufacturing facilities. And more. |
By Darren Incorvaia,Zoey Becker In the wake of the high-profile departure of Peter Marks, M.D., Ph.D., the FDA has a new leader for its Center for Biologics Evaluation and Research. FDA Commissioner Martin Makary, M.D., has named hematologist-oncologist Vinay Prasad, M.D., to the post. |
Fierce podcastsDon’t miss an episode |
| | This week on "The Top Line," Angela Hwang reflects on her leap from nearly 30 years at Pfizer to leading a biotech startup—and the career lessons that continue to guide her leadership and commitment to developing diverse talent. |
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Tuesday, May 20, 2025 | 11am ET / 8am PT This webinar will feature industry experts discussing the power of combining biomedical data analysis with matched tissue and molecular samples. Register today to learn more.
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| WhitepaperDon’t delay your gene transfer trial’s start-up timeline by gaining the latest insights from WCG’s case study on the power of a seamless Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC) review process. Sponsored by: WCG |
| WhitepaperWe interviewed 24 Medical Affairs leaders on the critical success factors for building a Best Practice Medical Affairs organization. This report shares what we learned. Presented by Blue Matter, strategic consultants in the life sciences |
| WhitepaperLearn how the SpyLock service can offer fast bispecific generation, reduce workload, and accelerate candidate selection. Sponsored by: Bio-Rad |
| eBookTypical vaccine development timelines have averaged 10 years, but the time from the SARS-CoV-2 genetic sequence’s release to the submission of the first vaccine clinical trial data for regulatory review was a mere 314 days. In IQVIA Laboratories’ Vaccine eBook we focus on how contract research organizations (CROs) can best leverage strategic partnerships with sponsors to prepare for the next pandemic. Sponsored by: IQVIA |
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